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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CONTINENTAL EUROPEAN 230 VOLT LEVEL 1 HOTLINE; WARMER, THERMAL, INFUSION FLUID
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SMITHS MEDICAL ASD, INC. CONTINENTAL EUROPEAN 230 VOLT LEVEL 1 HOTLINE; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-90
Device Problems Fluid/Blood Leak (1250); Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2024
Event Type  malfunction  
Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
Event Description
It was reported that the case is cracked near the drain tube elbow causing the water to leak out.There was no patient involvement and no patient harm/adverse event reported.
 
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Brand Name
CONTINENTAL EUROPEAN 230 VOLT LEVEL 1 HOTLINE
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan ln n
minneapolis MN 55442
Manufacturer Contact
reed covert
6000 nathan lane north
minneapolis, MN 55442
2247062300
MDR Report Key19015486
MDR Text Key339103034
Report Number3012307300-2024-01946
Device Sequence Number1
Product Code LGZ
UDI-Device Identifier50695085820909
UDI-Public50695085820909
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K911383
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHL-90
Device Catalogue NumberHL-90-UK-230
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2024
Date Manufacturer Received03/04/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/12/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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